WHO Pharmaceuticals Newsletter 2003, No. 05
(2003; 15 pages) View the PDF document
Table of Contents
Close this folderREGULATORY MATTERS
View the documentASTEMIZOLE - Withdrawn due to ventricular arrhythmias
View the documentBICALUTAMIDE - Withdrawn due to accelerated deaths
View the documentDACLIZUMAB - Warning about hypersensitivity reactions, increased mortality in cardiac transplant study
View the documentDANAZOL - Use restricted to second-line therapy in endometriosis
View the documentLEVACETYL-METHADOL - Product to be withdrawn due to adverse cardiac events; safer alternatives to be adopted
View the documentMOROCTOCOG ALFA - Reports of lack of effect in prophylaxis patients
View the documentNEFAZODONE - Sale discontinued due to adverse hepatic events
View the documentNIMESULIDE - Product under ‘special pharmacovigilance’
View the documentOSELTAMIVIR - Adverse reactions section to include acute renal failure, thrombocytopenia, leucopenia
View the documentPHENYLPROPAN-OLAMINE - New warnings on cardiovascular risks to be added
View the documentSOMATROPIN - Refused approval for use in AIDS-related wasting syndrome
View the documentTERFENADINE - Withdrawn due to ventricular arrhythmias
View the documentVALSARTAN - Reports of interstitial pneumonia
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE
Open this folder and view contentsMISCELLANY
 

PHENYLPROPAN-OLAMINE - New warnings on cardiovascular risks to be added

Japan. The Ministry of Health, Labour and Welfare (MHLW) has asked manufacturers of products containing phenylpropanolamine (PPA) to include new warnings on cardiovascular risks. The move follows several reports of cerebral haemorrhage and other problems associated with the use of PPA containing products. Around 170 products, mostly OTC cough and cold preparations containing PPA, are available in Japan. Although a US study published in 2000 suggested a link between PPA and haemorrhagic stroke, the Japanese government did not impose use restrictions at the time since the US study observations were based on a much higher dose (150 mg) used in appetite suppressants and diet aids compared with the more conservative maximum daily dose of 100 mg in the OTC preparations in Japan; appetite suppressants are not approved in Japan. The PPA products in Japan already carry warnings about the potential risk in people with a history of high blood pressure or other cardiovascular problems. Despite these, there have been several adverse drug reaction reports necessitating the current move by MHLW to include stricter warnings on possible side effects, including cerebral haemorrhage. The MHLW has not restricted sales but is encouraging manufacturers to develop non-PPA products. (Also see WHO Pharmaceuticals Newsletter No. 4, 1996).

Reference:
Scrip World Pharmaceutical News No. 2876, 15 Aug 2003.

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